OSD
- Product code
- OSD
- Device name
- Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5670
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250419 | 2026-07-27 | Plus EV Holdings, Inc. D/B/A Intimate … | Intimate Rose Pelvic Wand (Purple); Intimate Rose Be… | FDA |
Official FDA classification page: OSD
Classification and pathway per current FDA publications. Data from openFDA (CC0).